Thai FDA Medical Device Control Division / Medical devices
Thai FDA launches a new medical-device clinical trial application system
The Thai FDA Medical Device Control Division announced that its new system for medical-device clinical trial applications would open on 9 September 2026. Teams preparing new applications should check account access and the revised submission workflow.
What the announcement says
On 8 September 2026, the Thai FDA Medical Device Control Division (กองควบคุมเครื่องมือแพทย์) announced a new application system for medical-device clinical investigations. The system became available on 9 September 2026.
The official page links to separate instructions for creating an application in the new system. It does not state that product classification, technical-document requirements or clinical-trial approval criteria changed at the same time. The confirmed change is the application channel.
Practical impact
Manufacturers, importers, sponsors and CROs preparing a medical-device clinical investigation in Thailand should confirm account permissions and the new application-creation steps before filing. Existing clinical and product documents may still need to be checked against the new input fields and upload format.
The announcement does not confirm whether applications already in progress move automatically or how long the previous channel remains available. Teams with an active case should confirm the transition directly with the Thai FDA IDE unit.
Affected products and work
- Medical devices intended for clinical investigation in Thailand
- Investigational Device Exemption applications
- Medical-device manufacturers, importers and trial sponsors
- CROs and local regulatory teams
Official sources
- ประชาสัมพันธ์เปิดระบบเครื่องมือแพทย์สำหรับวิจัยทางคลินิก ระบบใหม่
Thai FDA Medical Device Control Division system announcement · September 8, 2026
This article provides general information based on official notices. Scope and filing obligations can vary by product, licence type and operator role; review the original notice together with the facts of each case.